Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT03581656
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Mitral Regurgitation due to degenerative mitral leaflet prolapse or flail
* Left Ventricular Ejection Fraction \>20%
* New York Heart Association functional class II to IV
* Able and willing to give informed consent and follow protocol procedures.
Exclusion Criteria:
* Life expectancy \<1 year
* Hemodynamic instability
* Severe untreated ischemic disease
* Pulmonary Hypertension
* Any prior mitral valve surgery or transcatheter mitral valve procedure
* Stroke or transient ischemic event within 30 days before randomization
* Patient is pregnant (urine human chorionic gonadotropin (HCG) test result positive), planning to be pregnant or lactating.
* Renal insufficiency
* Acute anemia
* Chronic obstructive pulmonary disease
* Severe right ventricular dysfunction
* Hepatic insufficiency
* Patient is participating in other investigational studies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03581656
Study Brief:
Protocol Section:
NCT03581656